Saint Louis, Missouri 63110

  • Colorectal Cancer

Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.


Study summary:

OBJECTIVES: - Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan. - Determine the time to treatment failure, time to overall response, duration of overall complete response, and time to progression in patients treated with this regimen. - Determine the 1-year survival and overall survival of patients treated with this regimen. - Determine the toxicity and safety profile of this regimen in these patients. - Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma - At least 1 measurable lesion - At least 10 mm by spiral CT scan - At least 20 mm by conventional techniques - Bone metastases, ascites, or pleural effusions are not considered measurable disease - No evidence of CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present or 10 times ULN if bone metastases present) - No known Gilbert's disease Renal: - Creatinine no greater than 1.5 times ULN - Creatinine clearance at least 50 mL/min Cardiovascular: - No clinically significant cardiac disease - No congestive heart failure - No symptomatic coronary artery disease - No cardiac arrhythmias uncontrolled with medication - No myocardial infarction within the past 12 months Gastrointestinal: - Able to swallow tablets - No lack of physical integrity of the upper gastrointestinal tract - No malabsorption syndrome Other: - No prior unanticipated severe reaction to fluoropyrimidine therapy - No hypersensitivity to fluorouracil - No history of uncontrolled seizures or CNS disorders - No psychological illness or condition that would preclude study entry - No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix - No serious infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy - No concurrent active or passive immunotherapy (e.g., 17-1A antibody) for colon cancer - No concurrent prophylactic hematopoietic growth factors Chemotherapy: - At least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy - No prior chemotherapy for metastatic colorectal cancer - No prior irinotecan or capecitabine - No other concurrent cytotoxic agents Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed) - No concurrent radiotherapy Surgery: - At least 4 weeks since prior major surgery and recovered - No prior organ allograft Other: - At least 4 weeks since prior participation in an investigational drug study - No other concurrent investigational drugs


Study is Available At:


Original ID:

CDR0000068843


NCT ID:

NCT00022698


Secondary ID:

ROCHE-ML16323


Study Acronym:


Brief Title:

Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer


Official Title:

A Phase II Study of Oral Xeloda in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Mike Andria
Study Chair
Hoffmann-La Roche

Study Dates

Start Date:March 2001
Verification Date:February 2005
Last Changed Date:July 23, 2008
First Received Date:August 10, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:capecitabine
Intervention Type:Drug
Name:irinotecan hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Meropol NJ, Gold PJ, Diasio RB, Andria M, Dhami M, Godfrey T, Kovatich AJ, Lund KA, Mitchell E, Schwarting R. Thymidine phosphorylase expression is associated with response to capecitabine plus irinotecan in patients with metastatic colorectal cancer. J Clin Oncol. 2006 Sep 1;24(25):4069-77.
PMID:16943524
Reference Type:Results Reference
Citation:Carlini LE, Meropol NJ, Bever J, Andria ML, Hill T, Gold P, Rogatko A, Wang H, Blanchard RL. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res. 2005 Feb 1;11(3):1226-36.
PMID:15709193

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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